NA 03.130.291Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982075505), received between May 4, 2017 and Apr 17, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE LOCKING MECHANISM OF THE REDUCTION FORCEPS WAS DISCOVERED BROKEN AT THE POINT WHERE THE SCREW ATTACHES TO FORCEPS, WHICH CAUSED IT NOT TO LOCK. THE ISSUE WAS DISCOVERED DURING ROUTINE INSPECTION OF THE DEVICE. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) REDUCTION FORCEPS FOR 1.3 TO 2.0MM SCREWS/SOFT LOCK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9971595 ↗
• MalfunctionMar 11, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INSPECTION OF THE REDUCTION FORCEP FOR SCREW IT WAS NOTICED THAT THE METAL BAND THAT ALLOWS THE QUICK RELEASE HANDLE ON THE REDUCTION FORCEP APPEARS TO HAVE BROKEN AWAY FROM THE SET SCREW. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9821796 ↗
• MalfunctionMay 4, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT IS REPORTED DURING A PROCEDURE TO REPAIR A FRACTURE OF THE FIFTH METACARPAL ON (B)(6) 2017, THE REDUCTION FORCEPS WOULD NOT ATTACH TO THE BONE. AS SURGEON ATTEMPTED TO APPLY THE DEVICE TO INSERT THE LAG SCREW, THE DEVICE SLID WHEN SURGEON ATTEMPTED TO CLOSE IT. SURGERY WAS DELAYED APPROXIMATELY 30 MINUTES. CONCOMITANT DEVICES REPORTED: SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6545808 ↗